Data / Medical devices / United States / Mediusa Inc.
Mediusa Inc.: FDA-registered device maker in Los Angeles, CA, United States, 4 510(k) clearances
Mediusa Inc. is registered with the FDA (registration 3010713600) in Los Angeles, CA, United States. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 7, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010713600
- Address
- 1055 W 7th Street, Los Angeles, CA, United States, 90017
- Owner or operator
- MediUSA Inc (10061830)
- Roles
- Remanufacturer, Repackager or relabeler
- First device listed
- May 20, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Silicone Hydrogel For Scar Management | PFP | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 7, 2020 | K200802 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| November 10, 2016 | K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| December 19, 2013 | K123030 | COMPRESSOR NEBULIZER MODEL MCN-S600XX | CAF | Substantially Equivalent | Dongguan Aidisy Machinery & Electronic Equipment C | accessdata.fda.gov |
| August 21, 2012 | K120921 | CLEVER CHOICE | CGA | Substantially Equivalent | Simple Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Dehydrogenase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Glucose Oxidase, Glucose
Updated October 7, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.